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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

NCT ID: NCT03558152

Last Updated: 2023-04-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-26

Study Completion Date

2021-12-15

Brief Summary

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This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Group Type EXPERIMENTAL

UTTR1147A

Intervention Type DRUG

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Group Type EXPERIMENTAL

UTTR1147A

Intervention Type DRUG

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

UTTR1147A Placebo

Intervention Type DRUG

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Group Type EXPERIMENTAL

UTTR1147A

Intervention Type DRUG

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Group Type EXPERIMENTAL

UTTR1147A

Intervention Type DRUG

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

UTTR1147A Placebo

Intervention Type DRUG

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Group Type EXPERIMENTAL

UTTR1147A

Intervention Type DRUG

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Group Type EXPERIMENTAL

UTTR1147A

Intervention Type DRUG

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

UTTR1147A Placebo

Intervention Type DRUG

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Arm 4: Vedolizumab

Parts A and B: Vedolizumab and UTTR1147A Placebo.

Group Type ACTIVE_COMPARATOR

UTTR1147A Placebo

Intervention Type DRUG

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Vedolizumab

Intervention Type DRUG

Vedolizumab will be administered IV, as specified in the prescribing information.

Arm 5: Placebo

Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

Group Type PLACEBO_COMPARATOR

UTTR1147A Placebo

Intervention Type DRUG

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Vedolizumab Placebo

Intervention Type DRUG

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Interventions

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UTTR1147A

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

Intervention Type DRUG

UTTR1147A Placebo

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Intervention Type DRUG

Vedolizumab

Vedolizumab will be administered IV, as specified in the prescribing information.

Intervention Type DRUG

Vedolizumab Placebo

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Intervention Type DRUG

Other Intervention Names

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Efmarodocokin alfa RO7021610 RG7880 IL-22Fc Entyvio

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of UC
* Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
* Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor \[TNF\] inhibitors \[maximum of 2 prior TNF inhibitors\]) and/or corticosteroid treatment
* Use of highly effective contraception as defined by the protocol

Exclusion Criteria

* History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
* History of cancer as defined by the protocol
* Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
* Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
* Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
* Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
* Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
* History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
* Prior treatment with UTTR1147A
* Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
* Prior treatment with rituximab
* Use of prohibited therapies, as defined by the protocol, prior to randomization
* Congenital or acquired immune deficiency
* Evidence or treatment of infections or history of infections, as defined by the protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Carolina Digestive Diseases

Greenville, North Carolina, United States

Site Status

University of Utah School of Medicine; Gastroenterology Division

Salt Lake City, Utah, United States

Site Status

MHAT Saint Karidad EAD

Plovdiv, , Bulgaria

Site Status

Multiprofile Hospital for Active Treatment Hadji Dimitar OOD

Sliven, , Bulgaria

Site Status

LLC ARENSIA Exploratory Medicine

Tbilisi, , Georgia

Site Status

Gastroenterologische Spezialpraxis-Berlin-Karlshorst

Berlin, , Germany

Site Status

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , Germany

Site Status

St. Marien Krankenhaus; Med. Klinik

Ludwigshafen, , Germany

Site Status

Universitatsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status

Universitätsklinikum Ulm; Klinik für Innere Medizin II

Ulm, , Germany

Site Status

Iatriko Palaiou Falirou; Gastrointestinal Department

Palaió Fáliro, , Greece

Site Status

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, , Greece

Site Status

Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ

Budapest, , Hungary

Site Status

Portiuncula Hospital, Ballinasloe

Co Galway, , Ireland

Site Status

Shaare Zedek Medical Center; Bait Vagan

Jerusalem, , Israel

Site Status

Policlinico Universitario Campus Biomedico Di Roma

Rome, Lazio, Italy

Site Status

Complesso Integrato Columbus

Rome, Lazio, Italy

Site Status

ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore

Monza, Lombardy, Italy

Site Status

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, Italy

Site Status

Azienda Ospedaliera Di Padova

Padua, Veneto, Italy

Site Status

ICS ARENSIA Exploratory Medicine

Chisinau, , Moldova

Site Status

SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.

?ód?, , Poland

Site Status

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej

Bydgoszcz, , Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Cz?stochowa, , Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gda?sk, , Poland

Site Status

Synexus - Katowice

Katowice, , Poland

Site Status

Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii

Katowice, , Poland

Site Status

ETG Kielce

Kielce, , Poland

Site Status

Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, , Poland

Site Status

Klimed Marek Klimkiewicz

Piotrkow Trybunalski, , Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Późna, , Poland

Site Status

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

Późna, , Poland

Site Status

Endoskopia Sp. z o.o.

Sopot, , Poland

Site Status

Gastromed Kopon Zmudzinski i

Toru?, , Poland

Site Status

Centrum Zdrowia MDM

Warsaw, , Poland

Site Status

Jaroslaw Kierkus Prywatna Prakyka Lekarska

Warsaw, , Poland

Site Status

Przychodnia EuroMediCare

Wroc?aw, , Poland

Site Status

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroc?aw, , Poland

Site Status

Melita Medical

Wroc?aw, , Poland

Site Status

Saint Martyr Elizabeth City Hospital

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science

Irkutsk, , Russia

Site Status

Rostov State Medical University; Cardiorheumatology Department

Rostov-on-Don, , Russia

Site Status

North-West State Medical University n.a. I.I. Mechnikov

Saint Petersburg, , Russia

Site Status

Medical University Reaviz

Samara, , Russia

Site Status

Clinical Hospital Center Zvezdara

Belgrade, , Serbia

Site Status

KBC Dr Dragisa Misovic Dedinje

Belgrade, , Serbia

Site Status

University Hospital Medical Center Bezanijska kosa

Belgrade, , Serbia

Site Status

Clinical Center Kragujevac; Clinic Of Psychiatry

Kragujevac, , Serbia

Site Status

General Hospital Vrsac

Vršac, , Serbia

Site Status

Clinical Hospital Centre Zemun

Zemun, , Serbia

Site Status

General Hospital Djordje Joanovic - Zrenjanin

Zrenjanin, , Serbia

Site Status

Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, Spain

Site Status

Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department

Chernivtsi, Chernihiv Governorate, Ukraine

Site Status

Medical Centre of PE First Private Clinic

Zhytomyr, Crimean Regional Governmenta, Ukraine

Site Status

Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology

Ternopil, Katerynoslav Governorate, Ukraine

Site Status

City Clinical Hospital #1; Department of Gastroenterology

Vinnytsia, Kharkiv Governorate, Ukraine

Site Status

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, Kharkiv Governorate, Ukraine

Site Status

ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

Dnipro, KIEV Governorate, Ukraine

Site Status

Treatment and Diagnostic Center of LLC MRT Elit

Kropyvnytskyi, KIEV Governorate, Ukraine

Site Status

Medical Center of LLC Medical Clinic Blagomed

Kyiv, KIEV Governorate, Ukraine

Site Status

Medical Center of Limited Liability Company ?Harmoniya krasy?

Kyiv, KIEV Governorate, Ukraine

Site Status

Medical Center of LLC Medical Center Dopomoga Plus

Kyiv, KIEV Governorate, Ukraine

Site Status

Medical Center of Edelweiss Medics LLC

Kyiv, KIEV Governorate, Ukraine

Site Status

Synexus Affiliate - MC of LLC Medbud-Clinic

Kyiv, KIEV Governorate, Ukraine

Site Status

Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

Kyiv, KIEV Governorate, Ukraine

Site Status

Medical Center of LLC Diaservis

Zaporizhzhia, KIEV Governorate, Ukraine

Site Status

Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov

Vinnytsia, Podolia Governorate, Ukraine

Site Status

Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology

Dnipr, Polissya Okruha, Ukraine

Site Status

Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department

Uzhhorod, , Ukraine

Site Status

Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3

Zaporizhzhia, , Ukraine

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Countries

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United States Bulgaria Georgia Germany Greece Hungary Ireland Israel Italy Moldova Poland Russia Serbia Spain Ukraine United Kingdom

References

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Danese S, Rothenberg ME, Lim JJ, Ding HT, McBride JM, Chen Y, Dash A, Mar JS, Keir M, Peyrin-Biroulet L, Panes J, Colombel JF, Feagan B, Valentine JF, Schreiber S. A Randomized Phase II Study of Efmarodocokin Alfa, an interleukin-22 Agonist, Versus Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2025 Jul;23(8):1387-1397. doi: 10.1016/j.cgh.2024.11.013. Epub 2024 Dec 16.

Reference Type DERIVED
PMID: 39694207 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017-002350-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GA39925

Identifier Type: -

Identifier Source: org_study_id

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